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510(k) K863604

DISPOSABLE BLADES FOR ARTHROSCOPIC SURGICAL DEVICE by American Edwards Laboratories

K863604 is an FDA 510(k) premarket notification submitted by American Edwards Laboratories for the device "DISPOSABLE BLADES FOR ARTHROSCOPIC SURGICAL DEVICE". The FDA issued a decision of Substantially Equivalent on October 3, 1986. American Edwards Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 1986
Date Received
September 16, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by American Edwards Laboratories

  • K873485 — EDSLAB (R) OCCLUSION BALLOON CATHETER (December 3, 1987)
  • K872596 — TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30 (September 30, 1987)
  • K872529 — THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2 (September 15, 1987)
  • K870444 — HOMEPRO II VOLUMETRIC INFUSION PUMP (April 17, 1987)
  • K864997 — MEDTRAC VP VOLUMETRIC INFUSION PUMP (February 27, 1987)
  • K864330 — SHEAR FORCE GAUGE (January 6, 1987)
  • K862724 — VEIN VALVE CUTTER (January 2, 1987)
  • K863596 — CHIN-FOGARTY INFLATION DEVICE (November 20, 1986)
  • K864155 — MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS (November 20, 1986)
  • K863986 — XENON LIGHT SOURCE FOR ENDOSCOPIC PROCEDURES (October 31, 1986)

FDA data resources